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- Important Safety Information
- Approved Uses
- Prescribing Information
IMPORTANT SAFETY INFORMATION
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You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for FASLODEX
FASLODEX is a prescription medicine used to treat women with:
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
- HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
- HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX... Read More
Side effects of FASLODEX as treatment after previous hormonal therapy
Be sure to discuss any side effects with your doctor
As with any medication, you may experience side effects while taking FASLODEX. If you are concerned about any symptoms you may be experiencing, you should contact your doctor’s office right away. The most common side effects below were reported in the CONFIRM study.
Injection site pain
Nausea
Muscle, joint, and bone pain
Headache
Tiredness
Hot flashes
Vomiting
Loss of appetite
Weakness
Cough
Constipation
Shortness of breath
Increased liver enzymes
0.6% of patients receiving FASLODEX 500 mg and 0.8% of patients receiving FASLODEX 250 mg withdrew from treatment due to drug-related side effects.
Because FASLODEX is metabolized, or broken down, primarily in the liver, a monthly dose of 250 mg is recommended for patients with moderate liver problems.
It is not known if FASLODEX is effective in patients with severe liver problems.
IMPORTANT SAFETY INFORMATION
-
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for FASLODEX
FASLODEX is a prescription medicine used to treat women with:
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
- HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
- HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.
This site is intended for US consumers only.
The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about FASLODEX, talk to your doctor or pharmacist. Only you and your health care professional can decide if FASLODEX is right for you.
IMPORTANT SAFETY INFORMATION
-
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
- Have liver problems
- Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.
Approved Uses for FASLODEX
FASLODEX is a prescription medicine used to treat women with:
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
- HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
- HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).